Biopsy marker delivery system

ABSTRACT

An apparatus for delivering subcutaneous cavity marking devices. More particularly, the delivery devices may be used with biopsy systems permitting efficient placement of a biopsy marker within a cavity. The device may include an intermediate member which assists in deployment of the marking device. The devices may also include a deployment lock to prevent premature deployment of a biopsy marker. The invention may further include the capability to match an orientation of a biopsy probe which has been rotated upon procurement of a biopsy sample.

FIELD OF THE INVENTION

[0001] This invention is directed to delivery devices for deliveringsubcutaneous cavity marking devices. More particularly, the deliverydevice may be used with biopsy systems permitting efficient placement ofa biopsy marker within a cavity. The device may include an intermediatemember which assists in deployment of the marking device. The device mayalso include a deployment lock to prevent premature deployment of abiopsy marker. The invention may further include the capability to matchan orientation of a biopsy probe that has been rotated upon procurementof a biopsy sample.

BACKGROUND OF THE INVENTION

[0002] Over 1.1 million breast biopsies are performed each year in theUnited States alone. Of these, about 80% of the lesions excised duringbiopsy are found to be benign while about 20% of these lesions aremalignant.

[0003] In the field of breast cancer, stereotactically guided andpercutaneous biopsy procedures have increased in frequency as well as inaccuracy as modem imaging techniques allow the physician to locatelesions with ever-increasing precision. However, for any given biopsyprocedure, a subsequent examination of the biopsy site is very oftendesirable. There is an important need to determine the location, mostnotably the center, as well as the orientation and periphery of thesubcutaneous cavity from which the lesion is removed.

[0004] In those cases where the lesion is found to be benign, forexample, a follow-up examination of the biopsy site is often performedto ensure the absence of any suspect tissue and the proper healing ofthe cavity from which the tissue was removed. This is also the casewhere the lesion is found to be malignant and the physician is confidentthat all suspect tissue was removed and the tissue in the region of theperimeter of the cavity is “clean”.

[0005] In some cases, however, the physician may be concerned that theinitial biopsy failed to remove a sufficient amount of the lesion. Sucha lesion is colloquially referred to as a “dirty lesion” or “having adirty margin” and requires follow-up observation of any suspect tissuegrowth in the surrounding marginal area of the initial biopsy site.Thus, a re-excision of the original biopsy site must often be performed.In such a case, the perimeter of the cavity must be identified since thecavity may contain cancerous cells. Moreover, the site of the re-excisedprocedure itself requires follow-up examination, providing furtherimpetus for accurate identification of the location of the re-excisedsite. Therefore, a new marker may be placed after re-excision.

[0006] While biopsy markers are well known, examples of improved biopsymarkers are described in U.S. patent application Ser. No. 09/285,329entitled “SUBCUTANEOUS CAVITY MARKING DEVICE AND METHOD” and 09/347,185entitled “SUBCUTANEOUS CAVITY MARKING DEVICE AND METHOD” each of whichis incorporated by reference herein. Placement of such biopsy markersmay occur through either invasive surgical excision of the biopsy, orminimally invasive procedures such as fine needle aspiration or vacuumassisted biopsy.

[0007] In a fine needle aspiration biopsy, a small sample of cells isdrawn by a thin needle from the lump or area of suspect tissue. If thesuspect area or lump cannot be easily felt, non-invasive imaging may beused to help the doctor guide the needle into the right area. A corebiopsy is similar to a fine needle aspiration biopsy, except that alarger needle is used. Under a local anaesthetic, the doctor makes avery small incision in the patient's skin and removes several narrowsections of tissue from the suspect area of tissue through the sameincision. The core biopsy provides a breast tissue sample rather thanjust individual cells. Thus making it easier for the pathologist toidentify any abnormalities.

[0008] Vacuum-assisted biopsy is performed through the skin and may relyupon ultrasound or stereotactic guidance to determine the location of asuspect area of tissue. Two commonly used vacuum-assisted breast biopsysystems are Mammotome® supplied by Johnson & Johnson EthiconEndo-surgery or MIBB® supplied by Tyco International. Examples of suchdevices may be found in U.S. Pat. No. 5,526,822 entitled “Methods andApparatus for Automated Biopsy and Collection of Soft Tissue,” U.S. Pat.No. 5,649,547 entitled “Methods and Devices for Automated Biopsy andCollection,” U.S. Pat. No. 6,142,955 entitled “Biopsy Apparatus andMethod” and U.S. Pat. No. 6,019,733 entitled “Biopsy Apparatus andMethod” the entirety of each of which is incorporated by referenceherein. Such breast biopsy systems include a probe that is insertedthrough the skin and is usually adapted to provide a vacuum to assist inobtaining the biopsy sample.

[0009] FIGS. 1A-1D illustrate an exemplary biopsy probe 10. Asillustrated, the distal ends of probes 10 of these biopsy systems areadapted to both penetrate tissue and to contain a cutting member 12which facilitates the removal of the biopsy sample. The cutting member12 will contain an aperture 14 (often referred to as a “probe window.”)The aperture 14 may be located on a side of a probe 10.

[0010] Once inserted through the skin, the cutting member 12 of theprobe 10 aligns with suspect tissue 1 via stereotactic, ultrasound, orother means. After proper positioning of the probe 10, a vacuum drawsthe breast tissue 1 through the probe aperture 14 into the probe 10. Asillustrated in FIG. 1B, once the tissue 1 is in the probe 10, thecutting member 12 actuates to capture a tissue sample 3. The tissuesample 3 may then be retrieved through the probe 10 to a tissuecollection area (e.g., a standard pathology tissue cassette). FIG. 1Cillustrates the probe 10 after the tissue sample is cleared from theaperture 14. Note that the illustration depicts a portion of the cuttingmember 12 as being retracted, leaving aperture 14 open; the cuttingmember 12 may alternatively be placed in a closed position duringretrieval of the tissue sample.

[0011] The biopsy system is often adapted such that the cutting member12 and aperture 14 rotate (e.g., via manipulation of a thumbwheel on theprobe or biopsy system) with respect to the biopsy system. Afterexcision of a tissue sample from the area of suspect tissue, theradiologist or surgeon may rotate the probe 10 and the aperture 14 to anew position relative to the biopsy system. FIG. 1D illustrates theprobe 10 and aperture 14 after being rotated but without being removedfrom the body. The rotation of the probe 10 and aperture 14 permitsexcision of multiple subsequent biopsy samples from a target area ofsuspect tissue with only a single insertion of the biopsy probe 10. Itshould be noted that FIG. 1D is provided merely to illustrate therotation of the probe 10 within the body. As such, the placement ofbiopsy markers is not illustrated in the figure. Moreover, the cuttingmember 12 is depicted in a closed position. This may ease rotation ofthe probe 10 within the tissue.

[0012] The entire cycle may be repeated until sampling of all desiredareas occurs (typically, 8 to 30 samples of breast tissue are taken upto 360 degrees around the suspect area). Accordingly, it is importantthat the operator of the biopsy system is able to identify theorientation of the probe aperture 14 relative to the biopsy system atany given time while the probe aperture 14 remains within the tissue.Often, demarcations on the thumbwheel permit the identification of theprobe orientation.

[0013] The above described removal of tissue samples creates tissuecavities. Hence, for reasons that are apparent to those familiar withsuch biopsy procedures, placement of a biopsy marker through the probeis most desirable. For example, repeated removal of the probe andinsertion of a biopsy marking device may cause unneeded additionaldiscomfort to the patient undergoing the procedure; removal of the probemay introduce error in placement of the biopsy marker into the desiredlocation; repeated removal and insertion of each of the devices mayprolong the duration of the procedure or spread cancer cells; after theprobe removes a tissue sample, it is in the optimal location to deposita marker; etc.

[0014] Biopsies may be performed with other tissue sampling devices asdescribed in U.S. Pat. Nos. 4,699,154; 4,944,308, and 4,953,558 theentirety of each of which is incorporated by reference herein. Suchdevices obtain a biopsy sample through a hollow biopsy needle having anaperture located in a distal end of the biopsy needle. As with thebiopsy devices previously described, once the tissue sampling devicesremoves tissue and creates a biopsy cavity, it may be desirable to placea marker in the area of the biopsy cavity.

[0015] In view of the above, there remains a need for an improved biopsymarker delivery system that may facilitate placement of a biopsy markerand also may be used with commercially available biopsy systems.

SUMMARY OF THE INVENTION

[0016] This invention relates to delivery systems for delivery of biopsycavity marking devices. A basic variation of the invention includes atissue marker delivery device comprising a tube having a lumen extendingtherethrough, a tissue marker removably seated in a distal end of thetube, a rod slidably located within the tube lumen and having a firstend extending through a proximal end of tube and a second end in thetube lumen; and an intermediate member separating the rod from thebiopsy marker, where advancement of the rod in a distal directiondisplaces the intermediate member to displace the tissue marker fromsaid marker seat. In a variation of this invention, the intermediatemember is discrete from both the rod and the tissue marker. Theintermediate member may comprises a flexible covering as describedherein.

[0017] Another variation of the invention includes a delivery device foruse with a biopsy probe having an aperture, the delivery devicecomprising a body having proximal and distal ends and a passagewayextending therethrough, an elongate sheath having a lumen extendingtherethrough, the sheath extending distally from the distal end of thebody, the sheath lumen in fluid communication with the body passageway,an access tube having a proximal and a distal end and a lumen extendingfrom at least a portion of the access tube through the proximal end, theaccess tube slidably located within the body passageway and the sheathlumen, a marker seat located towards the distal end of the access tube,a rod slidably located within the access tube lumen and having a firstend extending through the proximal end of the body and a second end incommunication with the marker seat, wherein advancement of the rod in adistal direction advances the marker seat distally until the marker seatis adjacent to the probe aperture such that a marker in the marker seatmay be deployed from the aperture. For example, when using a biopsyprobe having an aperture in a side wall of the probe, the marker seatmay be advanced within the aperture and subsequently deploys a marker.When the inventive device is used with biopsy probes having an aperturein a distal end of the probe, the marker seat may be advanced justproximal to the aperture in preparation for subsequent deployment of themarker.

[0018] The rod may advance the marker seat through a number ofconfigurations. For example, the rod may be sized to have aninterference fit with a portion of the access tube lumen. Anotherexample includes a device configured such that the rod engages a markerwhich is situated in the marker seat. In such a case, a sheath mayrestrain the marker in the marker seat. Thus, until the marker is nolonger constrained by the sheath, the rod will advance the marker withinthe sheath. In another variation, the rod may be in communication with afluid that is itself in communication with the marker seat. In such acase, the rod may apply a force on the fluid to advance the marker seatand/or displace a marker from the marker seat. In some variations, thefluid may serve to displace a flexible covering out of the marker seat.It is contemplated that the rod of the present invention may advance themarker seat through a combination of configurations either describedherein or known to those familiar with similar delivery devices.

[0019] A variation of the invention also includes a delivery device asdescribed above, wherein the body further comprises a keyway along thepassageway, and the body has an orientation being defined relative tothe keyway, the delivery device further comprising an access tube keylocated on the access tube and adapted to be slidably located within thebody keyway, the access tube key adapted to maintain an orientation ofthe access tube with the body orientation.

[0020] Variations of the invention may also include a deployment lockhaving a first end and a second end, the first end moveably located inthe body and the second end located outside of the body, the first endadapted to engage a portion of the rod to prevent at least distalmovement of the rod, whereupon disengagement of the first end of thedeployment lock from the portion of the rod permits distal movement ofthe rod. The deployment lock may be removable from the device or may bemoveable within the device so as to permit disengagement of the lockfrom the rod while still being attached to the body of the device.

[0021] The invention also may include a rod stop fixedly located on therod, wherein after the rod is advanced into the marker seat, the rodstop engages the access tube stop preventing further distal movement ofthe rod. The rod stop may also include a rod key that is adapted tomaintain an orientation of the rod with the body orientation.

[0022] A variation of the device includes an access tube stop fixedlylocated on a portion of the access tube being located within the body,wherein advancement of the rod in a distal direction advances the markerseat distally until the access tube stop engages the distal end of thebody preventing further distal movement of the access tube whereuponfurther distal advancement of the rod advances into the marker seat. Inone variation of the invention, engagement of the access tube stopagainst the distal end of the body places the marker seat adjacent tothe biopsy probe aperture.

[0023] In another variation of the invention a portion of the distal endof the access tube is removed to define the marker seat. The inventionmay also include a covering located over at least the marker seat, whereat least a portion of the covering is adapted to displace into and outof the marker seat. Movement of the rod into the marker seat displacesthe covering out of the marker seat. In variations of the inventionusing such a covering, there is no direct contact between the actuator(e.g., rod, etc.) and a marker placed within the marker seat.

[0024] In another variation of the invention, the inventive deviceincludes a delivery device key adapted to seat in the biopsy probe andmaintain an orientation of the access tube with an orientation of thebiopsy probe. The delivery device key may be located on the elongatedsheath or on the body of the device. In some variations of theinvention, seating the delivery device key in the biopsy probe willcause a distal end of the outer sheath to be placed immediately proximalto the biopsy probe aperture.

[0025] Variations of the invention also may include a biopsy marker thatis seated in the marker seat.

[0026] Although the delivery device and method described herein fordelivering a marking device to a subcutaneous cavity is suited for usewith a biopsy probe, the invention is not necessarily limited as such.Variations of the inventive device may be used with any type of biopsyprocedure.

[0027] The invention also contains a kit containing a biopsy markerdelivery device as described herein and an introducer cannula. Theintroducer cannula may be used to facilitate insertion of the deliverydevice into the patient to assist in delivery of a biopsy marker. Thekit may also include a biopsy probe. The biopsy probe may be aspring-loaded biopsy probe.

[0028] The invention also includes a method for marking a biopsy cavity.In one variation, the inventive method includes using a delivery devicehaving a marker, a tube removably seating the marker, a rod within thetube, and an intermediate member separating the rod and the marker, themethod comprising, advancing the marker and delivery device to thebiopsy cavity, actuating the rod to displace the intermediate member onthe delivery device; and depositing the marker in the cavity upondisplacing the intermediate member.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029]FIG. 1A illustrates biopsy probe for use with variations of thepresent invention.

[0030]FIG. 1B illustrates the biopsy probe of FIG. 1A in which tissue isdrawn through an aperture of the probe for excision of a biopsy sample.

[0031]FIG. 1C illustrates the biopsy probe of FIG. 1A where the biopsysample is cleared from the aperture.

[0032]FIG. 1D illustrates the biopsy probe of FIG. 1A rotated within thebody.

[0033]FIG. 2 provides a perspective view of a variation of a deliverydevice of the present invention.

[0034] FIGS. 3A-3K illustrate various components that may be used indelivery devices of the present invention.

[0035] FIGS. 4A-4C provide cross sectional views of a portion of adelivery device of the present invention during actuation of the device.

[0036] FIGS. 5A-5D illustrate cross sectional views of a delivery deviceof the present invention deploying a marker.

DETAILED DESCRIPTION OF THE INVENTION

[0037] The following discussion of the variations of the invention andthe reference to the attached drawings are for explanatory purposes anddo not exhaustively represent the possible combinations and variationsof the invention. Those skilled in the art will readily appreciate thatmany variations may be derived using the following description. Thefollowing examples are intended to convey certain principles of theinvention. These examples are not intended to limit the scope of theclaims to any particular example. It is understood that the claims areto be given their broadest reasonable interpretation in view of thedescription herein, any prior art, and the knowledge of those ofordinary skill in the field. Furthermore, it is understood that theinvention is not limited to the markers described herein. Instead, theinvention may be used with any type of biopsy marker or tissue marker.

[0038]FIG. 2 illustrates a perspective view of a variation of a biopsymarker delivery device 20 of the present invention. In this variation,the delivery device 20 includes a body 22 having an elongate sheath 28extending from a distal end 24 of the body 22 and a rod 30 extendingfrom a proximal end 26 of the body 22. This variation of the device 20also includes a deployment lock 32 having a first end 34 moveablylocated in the body 22 of the device 20 and second end 36 locatedoutside of the body 22. As discussed below, the first end 34 of thedeployment lock 32 engages a portion (not shown) of the rod 30preventing distal movement of the rod. Disengagement of the first end 34of the deployment lock 32 from the rod 30 permits movement of the rod 30within the device 20.

[0039] As will be apparent, the device 20 may incorporate features topermit ease in handling the device 20. For example, the proximal ends ofthe body 22 and the rod 30 each may have portions 40, 42 of increasedsurface area that assist in the ability to actuate the device. Also, thesecond end 36 of the deployment lock may have raised surface areas 44that permit an operator to grip the deployment lock 32 when an operatordisengages the first end 34 of the deployment lock 32 from the rod 30.Such features, which permit ease in handling the device, are well knownto those skilled in the art and are not meant to limit the scope of theinvention.

[0040]FIG. 3A illustrates a cross sectional view of a body 22 andelongate sheath 28 of a variation of the inventive device. In thisvariation, the body 22 has a proximal end 26, a distal end 24, and apassageway 46 extending through the body 22. The variation of the body22 depicted in FIG. 3A also contains a keyway 48 extending through atleast a portion of the body passageway 46. As described below, thekeyway 48 permits alignment and/or maintaining orientation of componentsof the inventive device with an orientation of the body 22. The abilityto identify an orientation of the device relative to, for example, abiopsy probe is desirable for proper deployment of a biopsy marker. Thekeyway 48 may be a male or female keyway which permits mating of acorresponding key such that a component having such a key will maintainorientation while moved through the device.

[0041] In the variation depicted in FIG. 3A, the distal end 24 of body22 includes an end component 50 that reduces a diameter of thepassageway 46 therethrough. It should be noted that the body 22 may beoptionally designed without such an end component 50. For example, thebody 22 could be designed as a unitary piece. In variations where thebody 22 is constructed as a unitary piece, the body passageway 46 mayoptionally have an area of reduced diameter at the distal end 24. Thisarea of reduced diameter made from a uniform reduction of the diameterof the passageway 46 or may have one or more protrusions whicheffectively reduce the diameter of the passageway 46. The body 22 mayalso include an opening 52 through which a deployment lock may beinserted through the body 22. As discussed above, the body 22 may alsoinclude a portion 40 of increased surface area that permits handling ofthe device. The body may be formed out of materials such as ABS,polycarbonate, acetal, or acrylic.

[0042] The inventive device also includes an elongate sheath 28extending distally from a distal end 24 of the body 22. The elongatesheath 28 contains a lumen (not shown) that extends through the sheath28. The sheath lumen is in fluid communication with the body passageway46. By fluid communication, it is meant that the passageways merelyintersect or join one another. The elongate sheath 28 may be flexiblesuch that the sheath 28 may be advanced to a biopsy site, either througha device, such as a biopsy probe, cannula, etc., or through a biopsytract created by the biopsy procedure. In any case, variations of theinvention may include sheaths 28 that may have sufficient rigidity toaccess the biopsy cavity (in some cases the sheath 28 may even contain areinforcing member, e.g., a braid, stiffening member.) The sheath maycomprise materials such as polyethylene (PE), especially high density PE(HDPE), nylon, urethane, or a fluoropolymer.

[0043] A variation of the inventive device, as illustrated in FIG. 3A,may also contain a delivery device key 38. The delivery device key 38may be located on the elongated sheath 28 (as illustrated) or may belocated on the body 22. As discussed above, it may be necessary torotate a biopsy probe to retrieve multiple tissue samples. The deliverydevice key 38 is adapted to be seated into a biopsy probe (not shown)such that when the biopsy probe is rotated, an orientation of the devicemay match the orientation of the aperture of the biopsy probe. Thedelivery device key 38 may include a raised protrusion or other surfacewhich may mate with a portion of the biopsy probe. In some variations ofthe inventive device, the length of the elongate sheath 28 is selectedsuch that when the delivery device key 38 is engaged in a biopsy probe,the distal end of the elongate sheath 28 is located adjacent to anaperture of the biopsy probe.

[0044]FIG. 3B illustrates a cross sectional view of a variation of adeployment lock 32 of the inventive device. The deployment lock 32includes a first end 34 and a second end 36. The first end 34 of thedeployment lock 32 is adapted to be inserted into the device body and toengage a portion of a rod (as illustrated below) to at least prevent therod from distal movement through the device. Thus, “locking” the device.The second end 36 of the deployment lock 32 may be located outside ofthe device body and is adapted to permit disengagement of the deploymentlock 32 from the rod. For example, the variation of the deployment lock32 depicted in FIG. 3B is adapted to be removed from the device viapulling the second end 36 of the deployment lock 32. While thisvariation of the deployment lock 32 is designed to be removed from thedevice, variations of deployment locks of the present invention mayremain within the device while simultaneously disengaging from a rod topermit movement of the rod. Additionally, variations of the deploymentlock 32 may also contain one or more securing arms 51, which assist inretention of the deployment lock 32 in a “locked” position.

[0045]FIG. 3C illustrates a side view of a rod 30 of the presentinvention. The rod 30 may be a tubular or other member. The rod 30 mayhave a lumen extending therethrough. The rod 30 may be flexible asrequired to navigate through a sheath which may itself be located in abiopsy probe. Some materials from which the rod may be constructedinclude nylon, urethane, PE, and fluoropolymers. As discussed above, therod 30 may have a portion 42 of increased surface area or increaseddiameter at a proximal end or along any length of the rod 30. The rod 30also includes a rod stop 54 located along a length of the rod 30. FIG.3D illustrates a cross sectional view of the rod stop 54 taken along theline 3D-3D of FIG. 3C. As shown in FIG. 3D, variations of the rod stop54 may include a rod key 56. The rod key 56 is adapted to mate with thebody keyway to maintain the orientation of the rod with respect to thedevice. Although the rod key 56 depicted in FIG. 3D is a male key, therod key 56 is intended to mate with the corresponding keyway.Accordingly, the rod key 56 may be a female rather than male fitting.Furthermore, the rod key 56 of the present invention is not limited toplacement on the rod stop 54. For example, variations of the inventivedevice may include a rod key which may be located on a rod 30 as opposedto the rod stop 54.

[0046]FIG. 3E illustrates a side view of a variation of an access tube58 of the present invention. The access tube 58 comprises proximal 68and distal ends 70 with a lumen 72 extending at least from a portion ofthe tube 58 through the proximal end 68. In some variations of theinvention, the lumen may extend throughout the tube. However, the lumenmay also be closed at a distal end 70 such that when a biopsy marker(not shown) is placed in a marker seat 62, the biopsy marker isprevented from advancing distally within the access tube. This isespecially useful when side ejection of a marker is desired. In such acase, the closed distal end 70 prevents a marker from remaining within aportion of the lumen 72 of the tube 58 at the distal end 70. The distalend 70 may be either closed or have a occluding member placed therein.The access tube 58 may be flexible as required by the procedure beingused to access a biopsy cavity. The access tube 58 may be constructedfrom materials such as nylon, urethane, PE, or a fluoropolymer.

[0047] As illustrated in FIG. 3E, the access tube may also include anaccess tube stop 60. In this variation, the access tube stop 60 islocated at the proximal end 68 of the access tube 58. However, theinvention is not limited as such as the access tube stop 60 may belocated over any portion of the access tube 58. FIG. 3F illustrates across-sectional view of the access tube stop 60 of FIG. 3E as takenalong lines 3F-3F. In this variation the access tube stop 60 alsocontains an access tube key 66. As discussed above, the access tube key66 mates with a body keyway such that the access tube 58 and marker seat62 are able to maintain a desired orientation within the device. Theaccess tube key 66 may be male or female depending upon the body keyway.

[0048] The access tube 58 will contain a marker seat 62 located towardsa distal end 70 of the tube 58. The marker seat 62 will be adapteddepending upon the biopsy marker used with the device. For example, amarker seat 62 may be formed by removing a portion of the access tube58. In some variations of the invention, the invention may have anintermediate member that separates the biopsy marker from the actuatingmember of the device (e.g., the rod, etc.) and ejects/deploys the markerfrom the device. The intermediate covering may be discrete from the tubeand tissue marker, e.g., a flexible covering 64 as described below.However, it is also contemplated that a portion of the tube itself couldbe configured to serve as the intermediate member (e.g., a weakenedsection of a tube that is adapted to fold into the tube lumen to seatthe marker and unfold from the lumen to deploy the marker.)

[0049] As described above, a variation of the invention includes anintermediate member that is a flexible covering 64. The flexiblecovering 64 may be located over a portion of the tube 58 which includesthe marker seat 62. FIG. 3G illustrates a cross-sectional view of themarker seat 62 taken along the line 3G-3G of FIG. 3E. FIG. 3Gillustrates the marker seat 62 covered by the flexible covering 64. Asshown, at least a portion of the flexible covering 64 is placed orfolded into the marker seat 62. In such variations, the flexiblecovering 64 assists in deployment of the marker as the flexible covering64 may be displaced and/or unfolded out of the marker seat 62. In anycase, when a flexible covering is used, there may be no contact betweenany actuator (e.g., rod, etc.) and marker. The flexible covering may bemade from any commercially available medical grade flexible materialsuch as polyethylene terephthalate (PET), polytetrafluoroethylene(PTFE), or FEP.

[0050]FIG. 3E also illustrates a rod 30 slidably located within theaccess tube 58 where a distal end of the rod 30 may be located adjacentto the marker seat 62. Distal advancement of the rod 30 advances theaccess tube 58 within the device. In one variation, the distal end ofthe rod 30 may be urged against a marker (not shown) seated in themarker seat 62. Since the marker will be constrained within the markerseat, which is located within an elongate sheath (not shown), the markerwill be unable to deploy from the marker seat 62. Accordingly, as aresult of the rod 30 pushing against the marker (constrained within themarker seat 62) the access tube 58 and marker seat 62 advance with therod 30. Once the marker is no longer constrained by a sheath, e.g., themarker and marker seat are either placed within or advanced out of anaperture of the biopsy probe, then the force of the rod 30 appliedagainst the marker will eject the marker from the marker seat 62.

[0051] In another variation, the distal end of the rod 30 and the lumen72 of the access tube 58 may be sized such to provide a friction fitbetween the lumen 72 and the rod 30. Thus, the friction fit permits therod 30 to advance the access tube 58 until the access tube 58 meets withsufficient resistance to permit the rod 30 to advance independently ofthe access tube 58. In any case, advancement of the rod 30 in a distaldirection advances the marker seat 62 distally until the marker seat 62is adjacent to the probe aperture such that a marker located in themarker seat 62 may be ejected from the probe aperture.

[0052] The invention includes variations where the rod advances themarker seat through a combination of configurations either describedherein or known to those familiar with similar delivery devices.

[0053]FIG. 3H illustrates a side view of a portion of the access tube 58of FIG. 3E. In this illustration, the rod 30 is able to advanceindependently of the access tube 58 and advances into the marker seat62. As a result, the rod 30 displaces and/or unfolds the flexiblecovering 64 out of the marker seat 62. Although not illustrated, thisaction permits the deployment of the marker (not shown) seated withinthe marker seat 62. In those variations of the invention not having aflexible covering 64, the rod 30 may deploy the marker via directcontact. In such cases, the distal end of the rod 30 is adapted toassist in deploying the marker (e.g., the distal end of the rod may betapered, rounded, hinged to eject the marker, etc.) Variations of theinvention also include a marker seat that permits deployment of a markerthrough a distal opening in the lumen of the elongate sheath.

[0054]FIG. 31 illustrates another variation of the present invention. Inthis variation, a rod 30 is slidably located within the access tube 58where a distal end 76 of the rod 30 is adjacent to a fluid 74. In thisvariation, distal advancement of the rod 30 also advances the accesstube 58 within the device when a marker (not shown) is constrained inthe marker seat 62 by an outer sheath (not shown.) Such a result occursas advancement of the rod 30 displaces the fluid 74. Because the markeris constrained in the marker seat 62, the fluid 74 cannot displace theflexible covering 64 from the marker seat 62. Instead, the force on thefluid 74 applied by the distal end 76 of the rod 30 acts to distallyadvance the marker seat 62 and marker out of the sheath. Once the markeris advanced out of the sheath and is no longer constrained, the forceapplied by the distal end 76 of the rod 30 displaces the fluid 74 whichdisplaces the flexible covering 64 thereby ejecting the marker from themarker seat 62.

[0055]FIG. 3J illustrates a state of the device after the marker isfreed from constraint by the sheath. As illustrated, the displacement ofthe fluid 74 by the distal end of the rod 76 displaces the flexiblecovering 64 from the marker seat 62 to eject the marker. As illustratedin FIGS. 3I and 3J, the distal end 76 of the rod 30 may be adapted suchthat it forms a seal (e.g., through sizing, use of a sealing gasket,etc.) with the lumen 72 of the access tube 58.

[0056] In some variations of the invention the rod 30 may be entirelyreplaced with fluid. In such a case, a syringe or similar apparatuswould provide an actuator/pressure source to displace the fluid anddeploy the marker. Moreover, the flexible covering 64 may also befluid-tight such that the fluid cannot escape from the device. Forexample, FIGS. 3I and 3J show the flexible covering 64 as having fluidtight seals 78. It is noted that the position of the seals 78, asillustrated, is merely for exemplary purposes as the seals may be placedin any position such that fluid does not escape. As is apparent, in mostcases, the distal end 70 of the access tube 58 will be sealed to preventleakage of the fluid 74. In some cases, the distal end 70 may be adaptedto deliver or leak the fluid in a controlled manner. The fluid 74 may beany biocompatible liquid or gas, e.g., saline fluid, air, etc. In somecases, as the rod 30 exerts a force on the fluid 74, the fluid maycompress 74. In such cases, it may become necessary to add additionalfluid 74 to the device.

[0057]FIG. 3K illustrates a variation of an access tube 58 for use withthe present invention. As illustrated, the distal end 70 of the accesstube 58 may be tapered to permit the access tube 58 to enter a cavitywhere tissue has collapsed or narrowed the tract entering the cavity.

[0058] It should be noted that the rod 30 and access tube 58 of thepresent invention may be sufficiently flexible to navigate through abiopsy probe, cannula, etc., to access a biopsy site. However, someapplications may require variations of the invention having a rigidaccess tube and rod.

[0059]FIG. 4A illustrates a cross sectional view of a portion of avariation of inventive delivery device 20. As illustrated, the device 20is in a “locked” position as the deployment lock 32 engages a portion ofthe rod 30 to prevent at least distal movement of the rod 30. In thisvariation, a first end 34 of the deployment lock 32 engages a rod stop54 on a rod 30. Although the deployment lock 32 may be removed from thebody 22, variations of the invention contemplate that the deploymentlock 32 may disengage from the rod 30 while remaining attached to thebody 22. As mentioned above, in variations of the device 20 for use witha biopsy probe (not shown), the device may have a delivery device key(not shown) as well. The delivery device key permits the orientation ofthe device to match the orientation of the probe aperture as it isrotated within the body of a patient. Moreover, the delivery device keymay be placed such that the distal end of the elongate sheath 28 isplaced adjacent to the probe aperture when the delivery device key isengaged to the biopsy probe.

[0060]FIG. 4B illustrates a cross sectional view of a portion of thevariation of the inventive delivery device 20 where the deployment lock(not shown) is removed from the body 22 via an opening 52 in the body22. As a result, the rod 30 is able to be advanced in a distal directionwithin the device 20. As described above, advancement of the rod 30permits advancement of a access tube 58 within the device 20. Asillustrated in FIG. 4B, once an access tube stop 60 engages a distal end24 of the body 22, the access tube 58 is prevented from further distalmovement. Therefore, once the access tube 58 advances out of a distalend of the elongated sheath 28, the access tube stop 60 engages thedistal end 24 of the body 22 preventing further distal movement.However, the access tube 58 advances sufficiently to permit advancementof the marker seat out of the distal end of the sheath 28. In somevariations of the inventive device 20, the body 22 may also contain akeyway (not shown) as discussed above. Accordingly, the access tube 58will contain a corresponding key which permits the orientation of theaccess tube to match the orientation of the device. Maintaining thisorientation may also permit the marker seat to be oriented within thedevice 20 such that it is aligned with an aperture of a probe to permitdeployment of the marker through the probe aperture.

[0061] In variations of the invention not having an access tube stop 60,distal movement of the rod 30 advances the marker seat distally due tothe distal end of the rod pushing against a marker within the markerseat. Since the marker is constrained by the sheath and/or biopsy probe,it remains within the marker seat. Once the marker is advanced out ofthe sheath 28 and is placed adjacent to the probe-aperture, it is nolonger constrained by the sheath 28 or the biopsy probe. At this point,further distal movement of the rod 30 ejects the now unconstrainedmarker from the marker seat through the probe aperture and into a biopsycavity.

[0062]FIG. 4C illustrates a cross sectional view of the device 20 ofFIG. 4B where the rod 30 is further distally advanced to deploy amarker. In this variation, the rod contains a rod stop 54 which limitsthe distal advancement of the rod 30. Accordingly, the device 20 will beconfigured such that the rod 30 is able to deploy the marker prior tobeing prevented from further distal advancement.

[0063] FIGS. 5A-5B illustrate a partial cross sectional view of avariation of a delivery device of the present invention for use with abiopsy probe 10. FIG. 5A illustrates the inventive delivery device afterthe access tube 58 is advanced out of the elongate sheath 28. Asdiscussed above, the elongate sheath 28 may be placed immediatelyadjacent to an aperture 14 of the probe 10 and the access tube 58 isadvanced within the aperture 14. Also as discussed above, the device maypermit orientation of the components of the device with the aperture 14of the probe 10.

[0064]FIG. 5B illustrates the invention where the rod 30 may moveindependently of the access tube 58. In variations of the device havinga marker 100 seated in the marker seat 62 upon a flexible covering 64,distal movement of the rod 30 may force the flexible covering 64 out ofthe marker seat 62 thereby deploying the marker 100.

[0065]FIG. 5C illustrates the use of the inventive device used with aprobe 10 that contains a distal aperture 14 (e.g., a biopsy needle,etc.) In this case, the device is advanced out of the aperture 14 sothat the marker 100 maybe deployed in a biopsy cavity. FIG. 5Dillustrates another variation of the inventive device where a distal end70 of the rod 30 permits advancement of the device through a tissuetract (the channel leading from the biopsy cavity to the outside of thepatient's body which is created during the biopsy procedure) that mayconstrict in diameter. It is noted that the sheath 28 may also beadapted to facilitate advancement through a narrowed tissue tract. Forinstance, if a biopsy probe is removed from the site, the deviceillustrated in FIG. 5D may be solely advanced into the tissue tract todeposit the biopsy marker 100. Furthermore, the device illustrated inFIG. 5D may be used with a biopsy probe as shown in FIG. 5C.

[0066] From the foregoing, it is understood that the invention providesan improved biopsy marker delivery system. While the above descriptionshave described the invention for use in the marking of biopsy cavitiesmade through a vacuum-assisted breast biopsy procedure, the invention isnot limited to such. The invention disclosed herein may be used with anybiopsy procedure discussed herein or otherwise known.

[0067] The invention herein has been described by examples and aparticularly desired way of practicing the invention has been described.However, the invention as claimed herein is not limited to that specificdescription in any manner. Equivalence to the description as hereinafterclaimed is considered to be within the scope of protection of thispatent.

We claim as our invention:
 1. A tissue marker delivery devicecomprising: a tube having a lumen extending therethrough; a tissuemarker removably seated in a distal end of said tube; a rod slidablylocated within said tube lumen and having a first end extending througha proximal end of tube and a second end in said tube lumen; and anintermediate member separating said rod from said biopsy marker, whereadvancement of said rod in a distal direction displaces saidintermediate member to displace said tissue marker from said markerseat.
 2. The tissue marker delivery device of claim 1, where saidintermediate member is discrete from both said rod and said tissuemarker.
 3. The tissue marker delivery device of claim 1, where saidintermediate member comprises a flexible covering.
 4. The tissue markerdelivery device of claim 1, further comprising a fluid between said rodand said intermediate member, where advancement of said rod in a distaldirection displaces said fluid member to displace said intermediatemember.
 5. The tissue marker delivery device of claim 1, furthercomprising a deployment lock having a portion removably attached to saidtube, wherein when said portion contacts said rod, said rod is preventedfrom moving.
 6. A biopsy marker delivery device for use with a biopsyprobe having an aperture, said delivery device comprising: a body havingproximal and distal ends and a passageway extending therethrough; anelongate sheath having a lumen extending therethrough, said sheathextending distally from said distal end of said body, said sheath lumenin fluid communication with said body passageway; an access tube havinga proximal and a distal end and a lumen extending from at least aportion of said access tube through said proximal end, said access tubeslidably located within said body passageway and said sheath lumen; amarker seat located towards said distal end of said access tube; and arod slidably located within said access tube lumen and having a firstend extending through said proximal end of said body and a second end incommunication with said marker seat, wherein advancement of said rod ina distal direction advances said marker seat distally; whereinadvancement of said rod in a distal direction advances said marker seatdistally until said marker seat is adjacent to the probe aperture,whereupon further distal advancement said rod advances into said markerseat.
 7. The delivery device of claim 6, wherein said body furthercomprises a keyway along said passageway, and said body having anorientation being defined relative to said keyway, said delivery devicefurther comprising an access tube key located on said access tube andadapted to be slidably located within said body keyway, said access tubekey adapted to maintain an orientation of said access tube with saidbody orientation.
 8. The delivery device of claim 7, further comprisinga delivery device key located on said body and adapted to seat in thebiopsy probe and maintain an orientation of said access tube with anorientation of the biopsy probe.
 9. The delivery device of claim 8,wherein a distal end of said outer sheath is immediately proximal to thebiopsy probe aperture upon seating of the delivery device key in thebiopsy probe.
 10. The delivery device of claim 7, further comprising anaccess tube stop fixedly located on a portion of said access tube beinglocated within said body, wherein advancement of said rod in a distaldirection advances said marker seat distally until said access tube stopengages said distal end of said body preventing further distal movementof said access tube, whereupon further distal advancement said rodadvances into said marker seat.
 11. The delivery device of claim 10,further comprising a rod stop fixedly located on said rod, wherein aftersaid rod is advanced into said marker seat, said rod stop engages saidaccess tube stop preventing further distal movement of said rod.
 12. Thedelivery device of claim 11, further comprising a rod key on said rod,said rod key adapted to maintain an orientation of said rod with saidbody orientation.
 13. The delivery device of claim 12 wherein said rodkey is located on said rod stop.
 14. The delivery device of claim 10,wherein engagement of said access tube stop against said distal end ofsaid body places said marker adjacent to the biopsy probe aperture. 15.The delivery device of claim 10, wherein said access tube key is locatedon said access tube stop.
 16. The delivery device of claim 6, furthercomprising a deployment lock having a first end and a second end, saidfirst end moveably located in said body and said second end locatedoutside of said body, said first end adapted to engage a portion of saidrod to prevent at least distal movement of said rod, whereupondisengagement of said first end of said deployment lock from saidportion of said rod permits distal movement of said rod.
 17. Thedelivery device of claim 16, further comprising a rod stop fixedlylocated on said rod, wherein said first end of said deployment lockengages said rod stop, and wherein after said rod is advanced into saidmarker seat, said rod stop engages said access tube stop preventingfurther distal movement of said rod.
 18. The delivery device of claim16, wherein said deployment lock is adapted to be removed from saidbody.
 19. The delivery device of claim 16, wherein said deployment lockfurther comprises at least one securing arm adapted to removably engagesaid body.
 20. The delivery device of claim 6, further comprising adelivery device key located on said sheath and adapted to seat in thebiopsy probe and maintain an orientation of said access tube with anorientation of the biopsy probe.
 21. The delivery device of claim 6,further comprising a biopsy marker placed in said marker seat andwherein said distal end of said access tube is closed such that saidbiopsy marker is prevented from moving distally in said access tube. 22.The delivery device of claim 6, wherein a portion of said distal end ofsaid access tube is removed to define said marker seat, said deliverydevice further comprising a flexible covering located over at least saidmarker seat, where at least a portion of said covering is adapted todisplace into and out of said marker seat, wherein movement of said rodinto said marker seat displaces said flexible covering out of saidmarker seat.
 23. The delivery device of claim 22, further comprising abiopsy marker seated on said flexible covering and in said marker seat.24. The delivery device of claim 22, wherein said flexible coveringcomprises PET.
 25. A delivery device for use with a biopsy probe havingan aperture, said delivery device comprising: a body having a proximaland distal ends and a passageway extending therethrough, said bodyhaving a keyway along said passageway, said body having an orientationdefined relative to said keyway; an elongate sheath having a lumenextending therethrough, said sheath extending distally from said distalend of said body, said sheath lumen in fluid communication with saidbody passageway; an access tube having a proximal and a distal end and alumen extending from at least a portion of said access tube through saidproximal end, said access tube slidably located within said bodypassageway and said sheath lumen, a portion of said distal end of saidaccess tube being removed to define a marker seat; an access tube keylocated on said access tube and adapted to be slidably located withinsaid body keyway, said access tube key adapted to maintain anorientation of said access tube with said body orientation; a flexiblecovering located over at least said marker seat, where at least aportion of said covering is adapted to displace into and out of saidmarker seat; a rod slidably located within said access tube lumen andhaving a first end extending through said proximal end of said body anda second end in communication with said marker seat, wherein advancementof said rod in a distal direction advances said marker seat distallyuntil said marker seat is adjacent to the probe aperture, whereuponfurther distal advancement said rod advances into said marker seatdisplacing said flexible covering out of said marker seat.
 26. Thedelivery device of claim 25, further comprising a delivery device keylocated on said sheath and adapted to seat in the biopsy probe andmaintain an orientation of said access tube with an orientation of thebiopsy probe.
 27. The delivery device of claim 26, wherein a distal endof said outer sheath is immediately proximal to the biopsy probeaperture upon seating of the delivery device key in the biopsy probe.28. The delivery device of claim 25, further comprising a deliverydevice key located on said sheath and adapted to seat in the biopsyprobe and maintain an orientation of said access tube with anorientation of the biopsy probe.
 29. The delivery device of claim 25,further comprising a rod stop fixedly located on said rod, wherein aftersaid rod is advanced into said marker seat, said rod stop engages saidaccess tube stop preventing further distal movement of said rod.
 30. Thedelivery device of claim 29, further comprising a rod key on said rod,said rod key adapted to maintain an orientation of said rod with saidbody orientation.
 31. The delivery device of claim 25, furthercomprising a deployment lock having a first end and a second end, saidfirst end moveably located in said body and said second end locatedoutside of said body, said first end adapted to engage a portion of saidrod to prevent at least distal movement of said rod, whereupondisengagement of said first end of said deployment lock from saidportion of said rod permits distal movement of said rod.
 32. Thedelivery device of claim 31, wherein said deployment lock is adapted tobe removed from said body.
 33. The delivery device of claim 31, whereinsaid deployment lock further comprises at least one securing arm adaptedto removably engage said body.
 34. The delivery device of claim 25,further comprising a biopsy marker seated on said flexible covering andin said marker seat.
 35. The delivery device of claim 25, wherein saidflexible covering comprises PET.
 36. The delivery device of claim 25,further comprising an access tube stop fixedly located on a portion ofsaid access tube being located within said body, wherein advancement ofsaid rod in a distal direction advances said marker seat distally untilsaid access tube stop engages said distal end of said body preventingfurther distal movement of said access tube, whereupon further distaladvancement said rod advances into said marker seat.
 37. The deliverydevice of claim 36, wherein engagement of said access tube stop againstsaid distal end of said body places said marker seat adjacent to thebiopsy probe aperture.
 38. The delivery device of claim 36, wherein saidaccess tube key is located on said access tube stop.
 39. A deliverydevice for use with a biopsy probe having an aperture, said deliverydevice comprising: a body having proximal and distal ends and apassageway extending therethrough; an elongate sheath having a lumenextending therethrough, said sheath extending distally from said distalend of said body, said sheath lumen in fluid communication with saidbody passageway; an access tube having a proximal and a distal end and alumen extending from at least a portion of said access tube through saidproximal end, said access tube slidably located within said bodypassageway and said sheath lumen; a portion of said distal end of saidaccess tube is removed to define a marker seat; a flexible coveringlocated over at least said marker seat, where at least a portion of saidcovering is adapted to displace into and out of said marker seat; and afluid located within said access tube lumen in said marker seat; saidfluid in communication with said flexible covering where displacement ofsaid fluid displaces said flexible covering out of said marker seat. 40.The delivery device of claim 39, where displacement of said fluid alsoadvances said marker seat.
 41. The delivery device of claim 39, furthercomprising a rod slidably located within said access tube lumen andhaving a first end extending through said proximal end of said body anda second end in communication with said fluid.
 42. The delivery deviceof claim 39, where said fluid extends through said proximal end of saidaccess tube.
 43. The delivery device of claim 42, further comprising asyringe in communication with said proximal end of said access tube,said syringe adapted to displace said fluid.
 44. A kit comprising: abiopsy marker delivery device as recited in any of claims 1-43; and anintroducer cannula.
 45. The kit of claim 44, further comprising a biopsyprobe.
 46. The kit of claim 45, where said biopsy probe is aspring-loaded biopsy probe.
 47. A method for marking a biopsy cavityusing a delivery device having a marker, a tube removably seating themarker, a rod within the tube, and an intermediate member separating therod and the marker, the method comprising: advancing the marker anddelivery device to the biopsy cavity; actuating the rod to displace theintermediate member on the delivery device; and depositing the marker inthe cavity upon displacing the intermediate member.